Hyalolex Hand Sanitizer Vitamin E + Aloe Vera Sulfate + paraben Free 70% Ethyl Alcohol Antimicrobial

Hyalolex Hand Sanitizer by

Drug Labeling and Warnings

Hyalolex Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by India Globalization Capital Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYALOLEX HAND SANITIZER- hand sanitizer liquid 
India Globalization Capital Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hyalolex Hand Sanitizer Vitamin E + Aloe Vera
Sulfate + paraben Free
70% Ethyl Alcohol
Antimicrobial

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic, Antimicrobial

Purpose

Antiseptic, Hand Sanitizer, Antimicrobial

Use

To help reduce germs on the skin

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

in or near the eyes. In case of contact, rinse eyes thoroughly with water

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use if irritation appears.

Keep out of reach of children.

Directions

  • Wet hands with product and briskly rub hands together until dry.
  • Supervise children under 6 years in use of this product.

Other information

  • Store between 20-25C (68-77F)
  • May discolor fabrics

Inactive ingredients

Purified water USP, Acrylate Copopyler, Glycerin, Carbomer, Propylene Glycol, Aloe Leaf Extract, Lemon Oil, Hydroxypropyl Methylcellulose, Tocopheryl Acetate

Package Label - Principal Display Panel

473 mL Bottle Label473 mL NDC: 75540-253-16

HYALOLEX HAND SANITIZER 
hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75540-253
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL 1-STEARATE (UNII: 32I3MRN561) 1 mL  in 100 mL
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 1 mL  in 100 mL
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H) 1 mL  in 100 mL
LEMON OIL (UNII: I9GRO824LL) 1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) 0.8 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 20.29 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.05 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75540-253-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/202004/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202004/30/2023
Labeler - India Globalization Capital Inc (364601877)

Revised: 2/2023